MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBJR051502A
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device evaluation is ongoing.
Event or Problem Description
The following was reported to gore: the gore® viabahn® endoprosthesis was advanced to the distal sfa popliteal area.The doctor began to pull the deployment line.The deployment line broke during deployment.The patient was taken to the or and the doctor surgically removed the device.
Additional Manufacturer Narrative
Examination of the returned device revealed the following: an introducer sheath was retuned but not evaluated as it is not a gore product; no endoprosthesis was returned; the deployment knob was connected to the deployment line measuring 153 cm with one fiber extending an additional 4.5 cm; there was some damage to the tip; the rest of the delivery catheter was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.All information has been placed on file for use in tracking and trending.Corrected date: results code 1 conclusions code 1.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7752852
• Report Number: 2017233-2018-00483
• Device Sequence Number: 1702985
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2020
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 17313031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR